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  • AstraZeneca and Ionis gene silencer Wainua fails trial after patients also took Pfizer heart drug
    At the ESC Congress in Munich, a high‑profile trial of the gene‑silencing therapy Wainua, developed by AstraZeneca and Ionis, was reported to have failed. The failure was linked to participants co…
    Endpoints · 13d agoNegative readoutNegative↗ source
  • BioNTech stops Phase 2 colorectal cancer mRNA vaccine trial after futility findings
    BioNTech announced that it is ending its Phase 2 study of a personalized mRNA vaccine for resected colorectal cancer after the trial failed to show the needed benefit. The news sent the company’s s…
    BioSpace · 12d agoNegative readoutNegative↗ source
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  • FDA clears updated COVID shots from Pfizer, Moderna and Novavax as Moderna raises $2.6 billion for cancer programs
    The FDA has granted limited approvals for updated versions of three COVID-19 vaccines aimed at the newly dominant XFG variant. The clearances cover Pfizer/BioNTech’s Comirnaty, Moderna’s mNEXSPIKE…
    BioPharma Dive · 12d agoRegulatoryPositive↗ source
  • BioXcel files for Chapter 11 bankruptcy, selling assets to Teva for up to $125 M
    BioXcel Therapeutics announced it has filed for Chapter 11 bankruptcy and plans to sell all of its assets. Teva Pharmaceuticals will serve as the stalking horse bidder, proposing an upfront paymen…
    BioSpace · 12d agoDealNegative↗ source
  • AstraZeneca and Amgen’s Tezspire eyes Dupixent’s EoE stronghold after late-stage trial win
    Analysts note that AstraZeneca and Amgen have secured a late‑stage trial win for Tezspire, positioning the drug as a possible challenger to Dupixent in eosinophilic esophagitis (EoE). Dupixent re…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • Cytokinetics reports positive pivotal trial results for aficamten in non-obstructive hypertrophic cardiomyopathy
    Biotech Cytokinetics disclosed full data from a pivotal study of its drug aficamten in patients with non-obstructive hypertrophic cardiomyopathy (nHCM). The trial met both primary endpoints, showin…
    STAT · 13d agoPositive readoutPositive↗ source
  • FDA greenlights Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera
    The U.S. Food and Drug Administration has granted approval to rusfertide, a therapy developed jointly by Takeda Pharmaceutical and Protagonist Therapeutics. The drug, to be marketed under the name…
    Endpoints · 12d agoApprovalPositive↗ source
  • BioNTech and Genentech halt Phase 2 trial of personalized mRNA cancer vaccine
    BioNTech and its partner Genentech announced the termination of a Phase 2 study evaluating a personalized mRNA cancer vaccine. The decision was made shortly after the trial had entered its second s…
    Endpoints · 13d agoNegative↗ source
  • CRISPR Therapeutics to test highest dose of lipid‑lowering gene editing therapy after mixed durability data
    CRISPR Therapeutics presented early‑stage data at the European Society of Cardiology meeting showing that its lipid‑lowering gene editing candidate produced mixed durability results a year after pa…
    Endpoints · 13d agoNegative readoutNeutral↗ source
  • Biotech Index Surges as IPOs and M&A Activity Accelerate in 2026
    The XBI biotech index, which had fallen to about $64 per share three years ago, has climbed back to near $170, almost doubling its value over the past year. Investor interest is reflected in a wav…
    BioPharma Dive · 13d agoPositive↗ source
  • AstraZeneca and Ionis report unexpected failure of heart disease drug in trial
    AstraZeneca and Ionis disclosed that their collaborative heart disease drug did not meet primary endpoints in a recent trial, marking a surprise setback. The companies detailed the trial results,…
    STAT · 13d agoNegative readoutNegative↗ source
  • Roche commits over $1 billion to DualityBio for ADC development targeting TOP1 resistance
    Roche's Genentech unit announced a major investment in DualityBio to advance antibody-drug conjugate (ADC) technology. Under the agreement DualityBio will receive an upfront payment of $45 million…
    Endpoints · 13d agoDealPositive↗ source
  • Cytokinetics aims for broader Myqorzo approval next year after supportive trial data
    Cytokinetics reported new data on its cardiac therapy Myqorzo, presented at a European scientific meeting. The results reinforce the drug’s efficacy in a specific heart muscle disorder. The compan…
    Endpoints · 13d agoApprovalPositive↗ source
  • Vaccine claims dominate federal autism advisory committee meeting, sidelining research funding plan
    At a recent meeting of the federal autism advisory committee, members spent most of the time discussing vaccines as a possible trigger for autism. The discussion eclipsed the committee’s intended…
    STAT · 13d agoNegative↗ source
  • Multispecific antibodies push CDMOs to redesign development platforms
    Manufacturers are moving beyond traditional monoclonal-antibody platforms as multispecific therapeutics gain traction. The new design model relies on molecular engineering, advanced analytics, and…
    BioSpace · 13d agoNeutral↗ source
  • CAR T therapy moves from cancer to autoimmune disease, leveraging oncology safety lessons
    Cell therapy that transformed treatment of blood cancers is now being tested for autoimmune disorders, according to a recent opinion piece. Early cancer trials showed high complete response rates…
    BioSpace · 13d agoPositive↗ source
  • FDA sends warning to Alar over misleading claims about investigational depression drug
    The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion sent an untitled warning letter to Alar Pharmaceuticals. The agency says Alar’s promotional materials for ALA-3000, an…
    raps · 13d agoRegulatoryNegative↗ source
  • FDA considers two new executive posts and approves first-of-its-kind early drug and ketone‑glucose wearable
    The Health and Human Services department is reportedly evaluating the creation of two additional senior positions within the FDA, a step that could increase agency oversight. In recent approvals,…
    raps · 13d agoRegulatoryNeutral↗ source
  • Juul receives FDA clearance for new e-cigarette with optional age-verification feature
    Juul Labs announced that the U.S. Food and Drug Administration has granted the company permission to market an updated version of its flagship vaping device. The new model, called Juul2, includes…
    STAT · 12d agoRegulatoryNeutral↗ source
  • FDA approves Roivant's new dermatomyositis therapy
    The FDA has granted approval to a therapy developed by Roivant for the treatment of dermatomyositis, a rare autoimmune condition that causes muscle inflammation and skin rash. The decision adds a…
    STAT · 13d agoApprovalPositive↗ source
  • Genentech strikes second Asia deal in a week, betting up to $1B in oncology ADC alliance with DualityBio
    Through its DualityBio deal, Roche's Genentech hopes to create antibody-drug conjugates with payloads that can circumvent growing cancer drug resistance.
    BioSpace · 13d agoDealNeutral↗ source
  • Former CDC leaders resign, warn of lingering political interference and call for stronger public health safeguards
    Three former CDC officials-Debra Houry, Daniel Jernigan, and Demetre Daskalakis-announced they resigned from the agency last year. Their careers included senior roles in disease control, emerging i…
    STAT · 13d agoRegulatoryNegative↗ source
  • AstraZeneca, Ionis data spark debate about RNA drugs’ impact on deadly heart disease
    Results published in NEJM raised questions about the benefits “silencer” medications provide on top of standard therapies for TTR cardiomyopathy and amplified investor pressure on Alnylam.
    BioPharma Dive · 12d agoRegulatoryNeutral↗ source
  • Daiichi Sankyo to restructure its commercial organization, appointing Ken Keller as chief commercialization officer
    Daiichi Sankyo announced plans to overhaul its commercial operations, with a split of its commercialization activities slated for April 1, 2027. The company has appointed veteran executive Ken Kel…
    Endpoints · 13d agoNeutral↗ source
  • Federal autism advisory panel reaffirms discredited theories amid vaccine controversy
    At a recent meeting of the federal autism advisory committee, members again promoted theories linking vaccines to autism that have been repeatedly disproven by scientific studies. The discussion c…
    STAT · 13d agoNegative↗ source